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Prostate Cancer Imaging Study with DBSI

This study is testing a new imaging method called Diffusion Basis Spectrum Imaging (DBSI) to see if it can accurately detect prostate cancer. DBSI is a non-invasive (does not involve surgery or breaking the skin) way to find significant prostate cancer early. Researchers will compare the results from DBSI to standard biopsy results to see how well DBSI works. You may be able to join if you are a man over 18, have not been diagnosed with prostate cancer before, and are planning to have a prostate biopsy as part of your usual care. This includes men with high PSA levels (a blood test that can indicate prostate problems). The study aims to enroll 500 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 500 male participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo an MRI with DBSI analysis, which will take about 1 hour of your time.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes of the study will be measured up to 12 weeks after the imaging procedure.

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NCT04420702

Diffusion Basis Spectrum Imaging of the Prostate

Recruiting
NAAges 18+InterventionalDiagnostic
Washington University School of Medicine
~500 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:MRI with DBSI analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the curve (AUC) comparison from biopsy and DBSI
Measured over Up to 12 weeks
+2 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Joseph Ippolito, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Joseph Ippolito, M.D.
[email protected]
314-362-2925
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Eligibility criteria

Inclusion

Over 18 years of age and willing and able to provide informed consent.
Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
Including those men with:
an elevated PSA and no prior biopsy
an elevated PSA and a negative prior biopsy
Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")

Exclusion

Patients with any clinical contraindication to MRI
Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
Those with cochlear implants
Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
Those who cannot lie flat for over 1 hour
Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

What this trial measures

  • Area under the curve (AUC) comparison from biopsy and DBSIUp to 12 weeks

    * As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard * In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.

  • Receiver operating characteristic (ROC) comparison from biopsy to DBSIUp to 12 weeks

    * As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard * In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.

  • Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sectorUp to 12 weeks